Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis

Conditions

• Polyarticular Course Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Givinostat — DRUG
  1.0 mg/kg daily (0.5 mg/kg twice a day) in fed condition 1.5 mg/kg daily (0.75 mg/kg twice a day) in fed condition

Study Details

The present study has been designed in order to evaluate the efficacy and safety of two doses of Givinostat in subjects with polyarticular course JIA Givinostat ready-to-use suspension especially intended for paediatric administration, will be administered orally at different daily doses. Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without active systemic features) will be enrolled. The treatment regimen will remain unchanged for 12 weeks and the clinical response will by assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR Pediatric 30 response will continue receiving the assigned dose for 12 further weeks. After the end of study (week 24) responder patients will be allowed to extend the treatment until they maintain a clinical benefit.

Key Dates

Start date

Oct 31, 2010

Status verified

Mar 2014

Primary completion

Jun 30, 2012

Completion

Mar 31, 2013

Study Design

Enrollment

16 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Givinostat 1.0 mg/kg daily
• Experimental: Givinostat 1.5 mg/kg daily

Primary Outcome Measure

ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment [ Time Frame: 12 weeks of treatment ]